Senior Site Navigator - FSO

Fortrea is looking for an experienced clinical operations professional to join our team as Senior Site Navigator, with a strong focus on clinical trial start‑up activities and in-house CRA responsibilities. This role is ideal for someone with solid start‑up expertise who is ready to take ownership of key processes within a global CRO environment.

Key responsibilities

Manage site identification, feasibility, and full start‑up activities, including site outreach, feasibility questionnaires, and confidentiality agreements
Lead and coordinate Ethics Committee and Regulatory Authority submissions, including initial submissions and amendments
Drive and track essential regulatory documents to ensure timely and compliant site activation
Act as primary point of contact for investigative sites during start‑up and early study phases
Independently manage site contract and budget negotiations in collaboration with internal stakeholders
Perform remote Pre‑Study Visits and support Site Initiation Visit preparation
Conduct in‑house CRA activities such as document review, CRF review, data validation, and remote monitoring tasks
Ensure TMF completeness and inspection readiness
Collaborate closely with CRAs, project teams, and cross‑functional stakeholders to meet study timelines
 
Qualifications

University degree (life sciences preferred)
Minimum 3+ years of experience in Start‑Up
Strong hands-on experience in clinical trial start‑up is essential
Proven experience with EC/RA submissions and regulatory documentation
Solid experience in contract and budget negotiations
Good knowledge of ICH/GCP and clinical trial processes
Strong organizational skills, attention to detail, and proactive communication
Ability to manage multiple priorities independently in a structured way